Efficacy of SU 011248 in Head And Neck Carcinoma

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Preclinical studies as well as phase I and II trials have demonstrated that SU11248 has antitumor activity in renal cell carcinoma, breast cancer, neuroendocrine tumor and GIST. So at the light of these pre-clinical and clinical data, it seems interesting and promising to test SU011248 in these poor prognosis patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Treatments: Sunitinib

Criteria

Inclusion Criteria:

• Recurrent and/or metastatic head and neck squamous cell carcinoma not amenable to curative treatment with surgery and/or chemotherapy and/or radiation

• Recurrence must be confirmed by anatomopathology (cytology or biopsy)

• At least one measurable lesion by MRI or CT-scan

• Failed or relapsing after first line chemotherapy including a platinum* or a taxane-based chemotherapy regimen

• Patients ineligible for chemotherapy could be included in first line

• ECOG performance status 0 -2, in stable medical condition

• Patients must be able to swallow tablets

• Patients must have an expected survival of at least 3 months

• Paraffin-embedded tumor tissue available for immunohistochemistry

• Patients must be over 18 years old and must be able to give written informed consent

• Women of child-bearing age must have a negative pregnancy test

• Female patients of child-bearing age must use effective contraception until 3 months have elapsed after the last injection

• Patients must have normal organ function

• For patients with local recurrence and easily accessible tumors, acceptance of iterative biopsies to store tumor samples (Formaldehyde for immunochemistry, RNA later)

• Acceptance of giving 20 ml of blood for eventual pharmacogenomic analysis

• Acceptance of giving two plasma samples (3ml) at baseline and after 4 weeks of treatment with SU011248

• Signed informed consent prior to beginning protocol specific procedure

Exclusion Criteria:

• Non-squamous head and neck cancer

• Nasopharynx cancer

• Brain metastases

• More than two lines of chemotherapy for palliative treatment (except if chemotherapy was given as a part of a multimodal treatment given with a curative intent)

• Surgery or irradiation or investigational drugs within 4 weeks before study inclusion

• Other uncontrolled illnesses (active infections requiring antibiotics, bleeding disorders, …)

• Active uncontrolled coronary disease or cardiac insufficiency (Ejection fraction below 40%)

• Previous malignancy, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix

• Other concomitant anticancer therapies

• Previous treatment with anti-VEGF, PDGF, or kit therapies. EGFR therapy is not an exclusion criteria.

• Organic brain syndrome or significant psychiatric abnormality that would preclude participation in the full protocol and follow up.